QMS and Reporting Specialist

Job Description Position Overview • The QMS and Reporting Support Contractor position within AIQ will serve as an enabler of multiple QMS initiatives, as well as support reporting and data analysis deliverables. • This individual will report into the QMS and Reporting pillar of AIQ and partner with various GxP stakeholders who provide data input and deviation record ownership. Key Responsibilities • Deviation Training Program & Support Model Execution • Support implementation of a deviation investigator training pilot program, incorporating adult learning principles and hands-on application. • Develop training materials (case studies, templates, guidance tools) to improve investigation quality and consistency. • Partner with QA and deviation owners to establish a sustainable support model (office hours, coaching, knowledge resources). • Analyze training program effectiveness metrics (e.g., quality of investigations, cycle times, rework trends) to inform program improvements and scalability. 1. Quality Metrics, Scorecard & KPI Enhancement • Support execution and delivery of Quality scorecards, dashboards, and KPI frameworks. • Perform data aggregation, trending, and root-cause-oriented analysis across deviations, CAPAs, and change controls. • Support routine and ad hoc reporting requests for Quality Management Review and Quality Systems forums, ensuring data accuracy and consistency. • Provide project management support across QMS initiatives (timelines, deliverables, stakeholder follow-ups). 1. QMS Process Support & Technology Enablement • Assist with process mapping, gap assessments, and continuous improvement initiatives across QMS processes. • Support data governance and data clean-up initiatives within the QMS. • Leverage client-approved AI tools and technologies to advance analytics and enable Quality record completeness and accuracy. Qualifications: • Bachelor’s degree in Life Sciences, Engineering, or related discipline. • 3-5 years of experience in GxP Quality Systems, QA operations, or QMS program support. • Strong understanding of GMP, GLP, GCP regulations and ICH guidelines Demonstrated experience with: • Quality Management System processes. • Quality metrics, dashboards, and KPI development. • Data analysis and trending (Excel, Power BI, or equivalent tools). • Electronic quality management systems (Veeva strongly preferred). • Preferred Qualifications. • Bachelor's degree in related field. • Experience with electronic Learning Management Systems and Document Management Systems. • Experience with change management and organizational development.